Development of a Medical Device for the Rapid Assessment of Concussion (S11.007)

OBJECTIVE: To develop an EEG-based medical device that can be used to assess conscious awareness in a short time frame (e.g., five minutes), particularly in traumatic brain injury patients. BACKGROUND: Incidents of traumatic brain injury are pervasive in the community, yet many such incidents are not properly diagnosed or assessed, particularly in the context of athletics. Assessment by a trained physician in these cases is hampered by a lack of public knowledge of concussion, especially where neurological symptoms may be mild or hidden. Thus, a triage tool for in-community assessment of these mild cases is a subject of active research. DESIGN/METHODS: Based upon principles of auditory evoked potential electroencephalography, a prototype medical device was developed: the Halifax Consciousness Scanner (HCS). HCS consists of a headset containing earphones and EEG electrodes placed at specified positions upon the scalp, coupled to a portable EEG amplifier, an audio tone/speech generator, and wirelessly connected to a portable computer/tablet for analysis. Upon activation, HCS presents tones and phrases to the subject that assess cortical function in five indicia related to consciousness (sensory, attention, perception, memory, and language). The aim of HCS research has been to norm this information and to compare to cases of known traumatic brain injury (mild through severe) and other traumas that exhibit abnormal auditory evoked potential EEG. RESULTS: Collection across 100 subjects showed consistent responses across all 5 indicators used in HCS. Recording of 20 major brain injury patients, approximately age-matched to controls, showed a significant difference in cortical response as measured by comparison of HCS waveforms between groups. Studies are ongoing to determine the HCS response in mild traumatic brain injury as measured in athletes suffering a first-time reported concussion. CONCLUSIONS: Preliminary data suggest that the set of auditory evoked potentials implemented in HCS represent a promising means of identifying whether or not a subject has suffered a change of conscious awareness indicative of concussion. Disclosure: Dr. Weaver holds stock and/or stock options in Mindful Scientific Inc., Treventis Corp., and DeNovaMed Inc., which sponsored research in which Dr. Weaver was involved as an investigator. Dr. Tam has received personal compensation for activities with Mindful Scientific Inc. Dr. Barden has received personal compensation for activities with DeNovaMed Inc. Dr. Barden holds stock and/or stock options in Mindful Scientific Inc., DeNovaMed Inc., and Treventis Corp., which sponsored research in which Dr. Barden was involved as an investigator. Dr. Barden holds stock and/or stock options in Treventis Corp. Dr. D9Arcy has nothing to disclose. Dr. Kalra has received personal compensation for activities with Mindful Scientific Inc. Dr. Petley has nothing to disclose. Dr. Wei has received personal compensation for activities with Mindful Scientific Inc.